Pharmacogenomics ANDA SNP Clinical Study - Topotecan and Single Nucleotide Polymorphisms

NCT07145333 | Active Not Recruiting Phase 2 DMC FDA Drug

• 7 other identifiers: IND 178174 CommercialFWA00015357NPI-1831468511NPI-1023387701IRB00009424IORG0007849IND178174
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the relationship between drug target topoisomerase I gene single nucleotide polymorphisms and Topotecan therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Topotecan side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Conditions

SCLC

Keywords

SNP; Topotecan; TOPO; CYP; Genotype

Outcome Measures

Primary Outcomes (1)

• Find Topotecan Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

  1. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on Topotecan Capsule after lung tissue biopsy, like as the usual approach group. 2. Recruit 300 double blind random group separated SCLC patients currently used the Chemotherapy on China Import Topotecan Capsule after lung tissue biopsy, like as the study approach group. 3. Assay above every SCLC patient-specific Topotecan drug target (Topoisomerase I) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. 4. Assay above every SCLC patient-specific Topotecan drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.

  Duration up to 14 weeks

Study Arms (2)

Topotecan - usual

EXPERIMENTAL

* Topotecan Capsule * Chemotherapy * Topotecan Capsule * Usual Approach Group

Drug: Topotecan - usual

Topotecan - study

EXPERIMENTAL

* China Import Topotecan Capsule * Chemotherapy * China Import Topotecan Capsule * Study Approach Group

Drug: Topotecan - study

Interventions

Topotecan - usual DRUG

Topotecan Capsule

Also known as: Usual Topotecan Capsule Chemotherapy

Topotecan - usual

Topotecan - study DRUG

China Import Topotecan Capsule

Also known as: Study Topotecan Capsule Chemotherapy

Topotecan - study

Eligibility Criteria

• Age: 24 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Clinical diagnosis of Small Cell Lung Cancer (SCLC)
• \. Clinical lung tissue biopsy diagnosis of SCLC
• \. Suitable for enough lung tissue biopsy of SCLC
• \. Random and double blind
• \. Measurable disease
• \. Adequate organ functions
• \. Adequate performance status
• \. Age 24 years old and over
• \. Sign an informed consent form
• \. Receive blood-drawing

You may not qualify if:

• \. Pneumonectomy
• \. Treatment with other anti-cancer therapies and cannot be stopped currently
• \. Pregnancy
• \. Breast-feeding
• \. The patients with other serious intercurrent illness or infectious diseases
• \. Have more than one different kind of cancer at the same time
• \. Serious Allergy to Drugs
• \. Clot or Bleed Tendency
• \. Serious Risks or Serious Adverse Events of the drug product
• \. The prohibition of drug products
• \. Have no therapeutic effects
• \. Follow up to the most current label

Sponsors & Collaborators

• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead
• UnitedHealthcare: collaborator

Study Sites (1)

Medicine Invention Design Incorporation

Rockville, Maryland, 20853, United States

Location

Related Links

• FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \>

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. - IRB00009424 - IORG0007849

  STUDY CHAIR

• HAN XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

  STUDY DIRECTOR

• HAN ID XU, MD/PhD/FAPCR

  Medicine Invention Design, Inc. - IORG0007849 - NPI-1023387701

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., FAPCR, Sponsor-Investigator, Medical Director, IORG Director, Medical Monitor, Safety Officer, IRB Chair

Model Details: * The usual approach group (Oral) * The study approach group (Oral) (China Import)

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 28, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)